Trial | NCT00602784  Report issue

Title

Phase II Study of Immunization With a Hepatitis C Virus (HCV) Antigen Peptide Vaccine
Double Blind, Randomized, Multicenter, Phase II Study of Immunization With a Hepatitis C Virus (HCV) Antigen Peptide Vaccine Together With Polyarginine, HCV Peptide Vaccine Alone, or Polyarginine Alone, in Patients With Chronic HCV Having Not Responded to or Relapsed From Primary Standard HCV Therapy

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    ic41 ...

  • Study Participants

    66
The objectives are

to determine the immunological profile (CD4+, CD8+ cells, DTH) induced by immunization with HCV antigen peptide vaccine with polyarginine.
to document virological (HCV-RNA) and biochemical (ALT) responses following immunization with HCV antigen peptide vaccine with polyarginine.
to assess the safety of immunization with HCV antigen peptide vaccine with polyarginine.
This is a double blind, randomized, parallel group, controlled, multicenter phase II study.

60 patients will be enrolled and assigned to one of the 5 dose or control groups. Each study group will include 8 patients.

Each patient will receive a total of 6 injections according to the dose of the assigned study group. The injections will be administered subcutaneously in the upper arm once every four weeks for 5 months, i.e. at days 1, 29, 57, 85, 113 and 141.

The volume of each injection will be 0.5 ml in all groups.
Study Started
Nov 30
2002
Primary Completion
May 31
2004
Study Completion
Sep 30
2004
Last Update
Oct 19
2012
Estimate

Biological IC41

IC41-B-01/02 Experimental

peptide dose 0.00 mg, polyarginine dose 2.00 mg

IC41-C-01/02 Experimental

peptide dose: 5.00 mg, polyarginine dose: 0.00 mg

IC41-G-01/02 Experimental

peptide dose: 2.50 mg, polyarginine dose: 1.25 mg

IC41-H-01/02 Experimental

peptide dose: 2.50 mg, polyarginine dose: 2.00 mg

IC41-K-01/02 Experimental

peptide dose: 5.00 mg, polyarginine dose: 2.00 mg

Criteria 

Inclusion Criteria:

Diagnosis of chronic hepatitis C
Non-response to or relapse from primary standard HCV therapy
HLA A2 positive
HCV-RNA positive
HCV antibodies positive
Liver biopsy within 30 months prior to inclusion
Hematology and biochemistry laboratory results within the limits normally expected for the patient population (liver values maximal 5 times the upper limit of normal)
Male and female
From 18 to 65 years
Written informed consent obtained prior to study entry

Exclusion Criteria:

Any degree of liver cirrhosis or fibrosis of Ishak score ≥ 4 (for grading table, see APPENDIX 2: The Ishak Modified Hepatic Activity Index (HAI))
Any liver disease other than hepatitis C
History of autoimmune disease
Immunodeficiency including post-organ-transplantation
HIV infection
Immunosuppressive therapy
Any acute infections within 4 weeks prior to inclusion
History of severe hypersensitivity reactions, anaphylaxis or atopy
Diabetes mellitus, severe cardiopulmonary disorders, history of malignancy in the past 5 years
Active or passive vaccination within 2 months prior to enrolment, and concomitant vaccination throughout the study period
Pregnancy or lactation
Unreliable contraception
Alcohol consumption
Drug abuse or addiction within 12 months prior to inclusion
Participation in a methadone program
Participation in another study within 1 month prior to enrolment
No Results Posted